Overview
Ash Spec Ireland Ltd is seeking a Quality Manager for its Life Sciences operation in Mullingar, Ireland. This highly visible role reports to the Global Quality Director and oversees both Quality Assurance and Quality Control functions within a GMP regulated environment.
Responsibilities
Provide leadership and functional oversight of QA and QC teams, including direct supervision, coaching, and development of QA specialists and QC technicians/analysts.
Ensure appropriate resourcing, training, and capability within the Quality function.
Maintain a strong quality culture with clear accountability and GMP ownership.
Serve as the site Quality Management Representative, representing Ashland in regulatory inspections, certification audits, customer audits, and company visits.
Establish, implement, maintain and continuously improve QMS processes, reporting performance, compliance status, risks and improvement opportunities to senior and global management.
Oversee laboratory operations and activities, ensuring compliance with approved methods, SOPs, GMP and data integrity requirements.
Maintain laboratory readiness for inspections, including instrument qualification, calibration and documentation practices.
Manage deviations, non conformances, CAPAs, change controls, complaints and risk management activities.
Prepare and approve quality and regulatory documentation in accordance with internal procedures and external requirements.
Lead quality activities supporting product lifecycle and site initiatives, including new product introductions, process changes, scale up and technical transfers.
Oversee design verification/validation, test method development, shelf life activities and product commercialization from a quality perspective.
Lead site through regulatory and customer audits, ensuring timely and effective audit responses and sustainable corrective actions.
Qualifications
Level8 (or higher) qualification in Science (Chemistry) or related discipline; postgraduate degree an advantage.
3+years' experience in a GMP regulated manufacturing environment with people leadership responsibility.
Strong knowledge of QMS and regulatory compliance (ISO13485, IPEC GMP, ISO14971 or equivalent).
Proven experience managing deviations, CAPAs, change control, audits, supplier quality and complaints.
Working knowledge of key analytical QC techniques (e.g. IV, GC, ICP MS, KarlFischer, potentiometric titration, GPC/SEC, polarimetry) sufficient for laboratory oversight.
Understanding of equipment qualification, process validation and cross functional project delivery.
Strong problem solving, ethical judgement and ability to drive value through risk based decisions.
Benefits
Industry competitive salary and benefits.
Pay for performance incentive plans.
Diverse work environment where employees feel challenged and valued.
Equal Opportunity Employer
Ashland is a proud Equal Opportunity Employer. Minorities/Women/Veterans/Disabled/GenderIdentity/SexualOrientation. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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